Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01492582|
Recruitment Status : Recruiting
First Posted : December 15, 2011
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivor Prevention of Human Papillomavirus Infection||Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58) Other: laboratory biomarker analysis Other: survey administration Other: medical chart review||Phase 2|
I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.
III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.
AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1268 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Prevention (vaccine therapy)
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)
Other: laboratory biomarker analysis
Other: survey administration
Other: medical chart review
Other Name: chart review
- Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ]To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
- Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ]To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
- Safety/tolerability of the HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 7-14 days following last vaccine dose ]To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492582
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Wendy Landier, PhD, CRNP 205-638-2120 firstname.lastname@example.org|
|Principal Investigator: Wendy Landier, PhD, CRNP|
|United States, California|
|City of Hope Medical Center||Active, not recruiting|
|Duarte, California, United States, 91010|
|United States, Georgia|
|Emory University School Of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Karen Wasilewski-Masker, MD 404-536-5747 email@example.com|
|Principal Investigator: Karen Wasilewski-Masker, MD|
|United States, Michigan|
|University of Michigan||Active, not recruiting|
|Ann Arbor, Michigan, United States, 48109|
|United States, Tennessee|
|Saint Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: James Klosky, PhD 901-595-5057 firstname.lastname@example.org|
|Principal Investigator: James Klosky, PhD|
|Principal Investigator:||Wendy Landier, PhD, CRNP||University of Alabama at Birmingham|